Orbital EdemaPhase 4NCT06450392
The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery
A Phase 4 study testing Tranexamic acid injection, Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML) and normal saline - injection in people with Orbital Edema and Orbital Ecchymosis, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reducing bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Edema, Orbital Ecchymosis
- What is being tested?
- Tranexamic acid injection, Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML) and normal saline - injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
- Patients who are at least 18 years of age
- Patients that have the capacity to consent
Who cannot join
- Any history of previous orbital surgery
- Any patient undergoing multiple simultaneous periocular surgical procedures
- Any patient with active infection
- History of stroke or seizure
- History of bleeding/clotting disorder
- Patients who do not comply with the required postoperative follow-up schedule
Show all 9Show fewer
- Patients who are allergic to tranexamic acid
- Patients who have taken anticoagulant/antiplatelet agents (including aspirin) within 7 days prior to surgery
- Patients who have periocular ecchymosis or edema prior to surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Anne Barmettler, MD, 718-920-4609, abarmett@montefiore.org
About this study
Official title: The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery - a Prospective, Multicenter, Randomized, Double-blinded, Control Trial
Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reducing bleeding. While recent studies have demonstrated the antifibrinolytic benefits of TXA in obstetric and gynecologic conditions, traumatic hemorrhage, cardiac surgery, total knee arthroplasty, and more, there is a paucity of clinical data on TXA use in plastic surgery. The aim of this study is to evaluate the effect of local and systemic TXA on postoperative periocular ecchymosis/edema in orbital surgery.
Read the detailed description
Patients, who will be undergoing orbital surgery anyways, will be given the option to participate in the study. Informed consent will be obtained in clinic during the preoperative consultation. On the day of surgery in the preoperative suite, study participants will be randomly allocated to one of three groups via computer-generated random numbers:
Group 1: will receive 1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery. Group 2: will receive 1.7 mL of subcutaneous tranexamic acid 100 mg/mL (Pfizer, New York, NY) with local anesthetic to the orbit two minutes prior to incision. Group 3: will receive intravenous normal saline and subcutaneous local anesthetic (i.e. standard procedure) as control group.
Twenty minutes before incision time, all patients will receive an intravenous solution. This will be either saline (placebo, participants in group 2 and 3) or 1g of tranexamic acid (participants in group 1). All operations will be performed using the standard of care technique and surgical instruments. All surgery will be performed under intravenous sedation with local anesthesia. Standard skin marking will be drawn, then the surgeon will inject each patient subcutaneously with either (1) a 5 cc mixture of TXA (100 mg/mL) mixed with 2% lidocaine with epinephrine and 0.5% marcaine with epinephrine in a 1:1:1 ratio (local TXA, Group 2) or (2) normal saline 0.9% sodium chloride mixed with 2% lidocaine with epinephrine and 0.5% marcaine with epinephrine in a 1:1:1 ratio (Group 1, Group 3). Degree of ecchymosis and edema in the postoperative photographs will be assessed separately by two graders. Graders will be blinded to treatment groups, and the photos will be completely deidentified.
Immediately following the procedure, the surgeon will take standardized photographs. The surgeon will also take standardized photographs at the regular 7-day postoperative visit. These photos will be deidentified and analyzed for degree of ecchymosis and edema by two blinded graders who will rate the photos using a standard five point grading scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) as described in the respective outcome measures.
- Conditions
- Orbital Edema, Orbital Ecchymosis
- Being tested
- Tranexamic acid injection, Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML), normal saline - injection, normal saline - intravenous
- Keywords
- Orbital Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
100 mg/mL (manufactured concentration) local TXA injection in the orbit
Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML)Drug
1g IV TXA
normal saline - injectionDrug
0.9% Normal Saline injection in the orbit
normal saline - intravenousDrug
0.9% IV Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Group 1: IV TXA | Experimental | 1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery Receives: Drug: Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML); Drug: normal saline - injection |
| Group 2: Local TXA | Experimental | 1-2mL of subcutaneous tranexamic acid 100 mg/mL (manufactured concentration, Pfizer, New York, NY) mixed with local anesthetic to the orbit two minutes prior to incision Receives: Drug: Tranexamic acid injection; Drug: normal saline - intravenous |
| Group 3: Control | Placebo comparator | Normal saline and subcutaneous local anesthetic to both eyelids (i.e. standard procedure) as control group Receives: Drug: normal saline - injection; Drug: normal saline - intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Ecchymosis
Degree of ecchymosis on postoperative day zero (POD0) and postoperative day 7 (POD7) as graded on a 5 point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) by two independent graders. The two scores will be averaged for inclusion in analysis. Scores will be aggregated to calculate means and standard deviations (SDs) for each group. Higher scores are associated with increased severity of ecchymosis.
Measured: 0 days and 7 days postoperatively
Degree of Edema
Degree of edema on postoperative day zero (POD0) and postoperative day 7 (POD7) as graded on a 5 point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) by two independent graders. The two scores will be averaged for inclusion in analysis. Scores will be aggregated to calculate means and standard deviations (SDs) for each group. Higher scores are associated with increased severity of edema.
Measured: 0 days and 7 days postoperatively
Secondary outcomes (3)
Patient Satisfaction with edema
Patients asked how satisfied they are with their edema postoperatively. Responses will be scored as 0 (not satisfied at all), 1 (somewhat unsatisfied), 2 (neutral), 3 (somewhat satisfied), or 4 (completely satisfied). Responses will be summed and mean scores and standard deviations (SDs) will be reported for each group. Higher scores correlate with increased degree of satisfaction.
Measured: 7 days postoperatively
Patient Satisfaction with ecchymosis
Patients asked how satisfied they are with their ecchymosis postoperatively. Responses will be scored as 0 (not satisfied at all), 1 (somewhat unsatisfied), 2 (neutral), 3 (somewhat satisfied), or 4 (completely satisfied). Responses will be summed and mean scores and standard deviations (SDs) will be reported for each group. Higher scores correlate with increased degree of satisfaction.
Measured: 7 days postoperatively
Other side effects
Patients will be asked if they had any seizure, focal weakness, lower extremity pain, difficulty breathing, chest pain, or any emergency room visit (to assess for adverse effects including thromboembolic event or seizure). Responses will be recorded as either "Thromboembolic event occurred" or "Thromboembolic event did not occur." Seizure events will be recorded in the same way. The number of patients with thromboembolic events and/or seizures will be summarized by the study arm.
Measured: 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start7 Oct 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Orbital EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized, double-blinded, controlled trial. On the day of surgery in the preoperative suite, study participants will be randomly allocated to one of three groups via computer-generated random numbers as described in the Arms and Interventions section.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Barmettler, Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450392
- Sponsor's protocol ID
- 2024-15945
- Status last verified
- Dec 2025
- First submitted
- 4 Jun 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kono S, Lee PAL, Kakizaki H, Takahashi Y. Orbital haematoma after orbital fracture repair using silicone, polytetrafluorethylene, and poly-L-lactic acid/hydroxyapatite implants. Br J Oral Maxillofac Surg. 2021 Nov;59(9):1036-1039. doi: 10.1016/j.bjoms.2021.01.002. Epub 2021 Jan 15.
PubMed 34531075Colomina MJ, Contreras L, Guilabert P, Koo M, M Ndez E, Sabate A. Clinical use of tranexamic acid: evidences and controversies. Braz J Anesthesiol. 2022 Nov-Dec;72(6):795-812. doi: 10.1016/j.bjane.2021.08.022. Epub 2021 Oct 7.
PubMed 34626756Paramo R, Cheng T, Malik A, Fan J, Barmettler A. Effect of Tranexamic Acid on Intra- and Postoperative Bleeding in Eyelid Surgery: A Prospective, Randomized, Multicenter, Double-Masked, Control Trial. Ophthalmic Plast Reconstr Surg. 2024 May-Jun 01;40(3):331-335. doi: 10.1097/IOP.0000000000002583. Epub 2024 Apr 12.
PubMed 38624153Marous CL, Farhat OJ, Cefalu M, Rothschild MI, Alapati S, Wladis EJ. Effects of Preoperative Intravenous Versus Subcutaneous Tranexamic Acid on Postoperative Periorbital Ecchymosis and Edema Following Upper Eyelid Blepharoplasty: A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Comparative Study. Ophthalmic Plast Reconstr Surg. 2024 Sep-Oct 01;40(5):523-532. doi: 10.1097/IOP.0000000000002633. Epub 2024 Apr 29.
PubMed 38687303Artymowicz, A., & Shinder, R. (2022). Effect of subcutaneous tranexamic acid on hemostasis and ecchymosis in dacryocystorhinostomy: A double-blind, placebo-controlled, randomized clinical trial. Poster session presented at the ASOPRS 2022 Conference, Chicago, IL, United States.
Zilinsky I, Barazani TB, Shenkman B, Weisman O, Farber N, Martinowitz U. Topical Hemostatic-Anesthetic Solution to Reduce Bleeding During Mohs Micrographic Surgery: A Case Control Study. J Drugs Dermatol. 2016 Jul 1;15(7):851-5.
PubMed 27391635Horrow JC, Van Riper DF, Strong MD, Grunewald KE, Parmet JL. The dose-response relationship of tranexamic acid. Anesthesiology. 1995 Feb;82(2):383-92. doi: 10.1097/00000542-199502000-00009.
PubMed 7856897Schroeder RJ 2nd, Langsdon PR. Effect of Local Tranexamic Acid on Hemostasis in Rhytidectomy. Facial Plast Surg Aesthet Med. 2020 May/Jun;22(3):195-199. doi: 10.1089/fpsam.2020.0061. Epub 2020 Mar 31.
PubMed 32228311
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery - a Prospective, Multicenter, Randomized, Double-blinded, Control Trial
- ClinicalTrials.gov ID
- NCT06450392
- Acronym / sponsor ID
- 2024-15945
- Conditions
- Orbital Edema, Orbital Ecchymosis
- Keywords
- Orbital Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reducing bleeding. While recent studies have demonstrated the antifibrinolytic benefits of TXA in obstetric and gynecologic conditions, traumatic hemorrhage, cardiac surgery, total knee arthroplasty, and more, there is a paucity of clinical data on TXA use in plastic surgery. The aim of this study is to evaluate the effect of local and systemic TXA on postoperative periocular ecchymosis/edema in orbital surgery.
Detailed description
Patients, who will be undergoing orbital surgery anyways, will be given the option to participate in the study. Informed consent will be obtained in clinic during the preoperative consultation. On the day of surgery in the preoperative suite, study participants will be randomly allocated to one of three groups via computer-generated random numbers:
Group 1: will receive 1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery. Group 2: will receive 1.7 mL of subcutaneous tranexamic acid 100 mg/mL (Pfizer, New York, NY) with local anesthetic to the orbit two minutes prior to incision. Group 3: will receive intravenous normal saline and subcutaneous local anesthetic (i.e. standard procedure) as control group.
Twenty minutes before incision time, all patients will receive an intravenous solution. This will be either saline (placebo, participants in group 2 and 3) or 1g of tranexamic acid (participants in group 1). All operations will be performed using the standard of care technique and surgical instruments. All surgery will be performed under intravenous sedation with local anesthesia. Standard skin marking will be drawn, then the surgeon will inject each patient subcutaneously with either (1) a 5 cc mixture of TXA (100 mg/mL) mixed with 2% lidocaine with epinephrine and 0.5% marcaine with epinephrine in a 1:1:1 ratio (local TXA, Group 2) or (2) normal saline 0.9% sodium chloride mixed with 2% lidocaine with epinephrine and 0.5% marcaine with epinephrine in a 1:1:1 ratio (Group 1, Group 3). Degree of ecchymosis and edema in the postoperative photographs will be assessed separately by two graders. Graders will be blinded to treatment groups, and the photos will be completely deidentified.
Immediately following the procedure, the surgeon will take standardized photographs. The surgeon will also take standardized photographs at the regular 7-day postoperative visit. These photos will be deidentified and analyzed for degree of ecchymosis and edema by two blinded graders who will rate the photos using a standard five point grading scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) as described in the respective outcome measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, multicenter, randomized, double-blinded, controlled trial. On the day of surgery in the preoperative suite, study participants will be randomly allocated to one of three groups via computer-generated random numbers as described in the Arms and Interventions section.
| Arm | Type | Receives |
|---|---|---|
| Group 1: IV TXA | Experimental | Drug: Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML), Drug: normal saline - injection1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery |
| Group 2: Local TXA | Experimental | Drug: Tranexamic acid injection, Drug: normal saline - intravenous1-2mL of subcutaneous tranexamic acid 100 mg/mL (manufactured concentration, Pfizer, New York, NY) mixed with local anesthetic to the orbit two minutes prior to incision |
| Group 3: Control | Placebo comparator | Drug: normal saline - injection, Drug: normal saline - intravenousNormal saline and subcutaneous local anesthetic to both eyelids (i.e. standard procedure) as control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
- Patients who are at least 18 years of age
- Patients that have the capacity to consent
Key exclusion criteria (9 listed)
- Any history of previous orbital surgery
- Any patient undergoing multiple simultaneous periocular surgical procedures
- Any patient with active infection
- History of stroke or seizure
- History of bleeding/clotting disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid injection100 mg/mL (manufactured concentration) local TXA injection in the orbit | Drug | Group 2: Local TXA |
| Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML)1g IV TXA | Drug | Group 1: IV TXA |
| normal saline - injection0.9% Normal Saline injection in the orbit | Drug | Group 1: IV TXA, Group 3: Control |
| normal saline - intravenous0.9% IV Normal Saline | Drug | Group 2: Local TXA, Group 3: Control |
Primary outcome
Degree of Ecchymosis
Time frame: 0 days and 7 days postoperatively
Degree of ecchymosis on postoperative day zero (POD0) and postoperative day 7 (POD7) as graded on a 5 point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) by two independent graders. The two scores will be averaged for inclusion in analysis. Scores will be aggregated to calculate means and standard deviations (SDs) for each group. Higher scores are associated with increased severity of ecchymosis.
Degree of Edema
Time frame: 0 days and 7 days postoperatively
Degree of edema on postoperative day zero (POD0) and postoperative day 7 (POD7) as graded on a 5 point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) by two independent graders. The two scores will be averaged for inclusion in analysis. Scores will be aggregated to calculate means and standard deviations (SDs) for each group. Higher scores are associated with increased severity of edema.
3 secondary outcomes
Patient Satisfaction with edema
Time frame: 7 days postoperatively
Patient Satisfaction with ecchymosis
Time frame: 7 days postoperatively
Other side effects
Time frame: 7 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 34531075Kono S, Lee PAL, Kakizaki H, Takahashi Y. Orbital haematoma after orbital fracture repair using silicone, polytetrafluorethylene, and poly-L-lactic acid/hydroxyapatite implants. Br J Oral Maxillofac Surg. 2021 Nov;59(9):1036-1039. doi: 10.1016/j.bjoms.2021.01.002. Epub 2021 Jan 15.
- Background: PubMed 34626756Colomina MJ, Contreras L, Guilabert P, Koo M, M Ndez E, Sabate A. Clinical use of tranexamic acid: evidences and controversies. Braz J Anesthesiol. 2022 Nov-Dec;72(6):795-812. doi: 10.1016/j.bjane.2021.08.022. Epub 2021 Oct 7.
- Background: PubMed 38624153Paramo R, Cheng T, Malik A, Fan J, Barmettler A. Effect of Tranexamic Acid on Intra- and Postoperative Bleeding in Eyelid Surgery: A Prospective, Randomized, Multicenter, Double-Masked, Control Trial. Ophthalmic Plast Reconstr Surg. 2024 May-Jun 01;40(3):331-335. doi: 10.1097/IOP.0000000000002583. Epub 2024 Apr 12.
- Background: PubMed 38687303Marous CL, Farhat OJ, Cefalu M, Rothschild MI, Alapati S, Wladis EJ. Effects of Preoperative Intravenous Versus Subcutaneous Tranexamic Acid on Postoperative Periorbital Ecchymosis and Edema Following Upper Eyelid Blepharoplasty: A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Comparative Study. Ophthalmic Plast Reconstr Surg. 2024 Sep-Oct 01;40(5):523-532. doi: 10.1097/IOP.0000000000002633. Epub 2024 Apr 29.
- BackgroundArtymowicz, A., & Shinder, R. (2022). Effect of subcutaneous tranexamic acid on hemostasis and ecchymosis in dacryocystorhinostomy: A double-blind, placebo-controlled, randomized clinical trial. Poster session presented at the ASOPRS 2022 Conference, Chicago, IL, United States.
- Background: PubMed 27391635Zilinsky I, Barazani TB, Shenkman B, Weisman O, Farber N, Martinowitz U. Topical Hemostatic-Anesthetic Solution to Reduce Bleeding During Mohs Micrographic Surgery: A Case Control Study. J Drugs Dermatol. 2016 Jul 1;15(7):851-5.
- Background: PubMed 7856897Horrow JC, Van Riper DF, Strong MD, Grunewald KE, Parmet JL. The dose-response relationship of tranexamic acid. Anesthesiology. 1995 Feb;82(2):383-92. doi: 10.1097/00000542-199502000-00009.
- Background: PubMed 32228311Schroeder RJ 2nd, Langsdon PR. Effect of Local Tranexamic Acid on Hemostasis in Rhytidectomy. Facial Plast Surg Aesthet Med. 2020 May/Jun;22(3):195-199. doi: 10.1089/fpsam.2020.0061. Epub 2020 Mar 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Barmettler principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid injection, Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML) and normal saline - injection in people with Orbital Edema and Orbital Ecchymosis, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Barmettler (718-920-4609, abarmett@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Ecchymosis (time frame: 0 days and 7 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06450392, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.